Prosthesis-Related Infections

Company Provides Update on Operations & EU Commercialization SAN JOSE, Calif., Jan. 15, 2025 /PRNewswire/ -- Silver Bullet Therapeutics, Inc., a privately-held medical device company, announced today that the Company now has approval to start a pre-market 510k study from the FDA. In addition, Silver Bullet Therapeutics is pleased to have formed a partnership with Merge Medical and will be featured in a podcast scheduled for broadcast March 2nd, 2025. Jeffrey Cole, MD and Jeffrey Brown, DO will also join their Scientific Advisory Board. The OrthoFuzIon™ Orthopedic System is a comprehensive antimicrobial coating technology. The first application is on a bone screw product line for orthopedic procedures. In the EU, the OrthoFuzIon Bone Screws are now approved for commercialization and indicated for open reduction and internal fixation (ORIF) fracture surgeries and are plated to inhibit microbial colonization and reduce implant related infection in revision surgery due to implant infection or primary surgery in patients who are at-risk of implant infections. Such infections often require reoperation and add significant costs which the hospital must often absorb. The FDA approved pre-market study titled, "Non-Inferiority Study of the Silver-Platinum Coated OrthoFuzIon™ Bone Screw System Against the Literature Related to Union/Non-Union Incidence on Lateral Malleolus Fractures (AO Classification 44A-44C) on Patients > 55 Years Old with a Co-Morbidity," is designed to objectively evaluate the impact of silver and OrthoFuzIon on orthopedic healing in support of the Company's 510k filing. Paul Chirico, President and CEO of Silver Bullet Therapeutics stated, "Silver Bullet has worked with the FDA for years to evaluate this technology. This is the first study for a permanent antimicrobial orthopedic implant. This is not only a major milestone for the practice of orthopedics but will provide clinically useful information and products in a relatively short period." Mr. Chirico added, "We are also pleased with the EU distributors we have evaluated that understand the significant strategic advantage to capturing long-term tenders against larger corporations with the only antimicrobial bone screw system in the world." Additionally, the company is pleased to announce a partnership with Merge Medical (mergemedical.org), a community of physicians passionate about the business of medicine, innovation, and startup investing. Together with Silver Bullet Therapeutics, Merge Medical is collaborating with healthcare startup Pitch Sink (pitchsink.com) to build an ecosystem featuring an on-demand talent-matching marketplace for MedTech innovators, supported by a vibrant network of physician advisors, investors, and key opinion leaders. "We are very excited about our partnership with Silver Bullet," states Dr. Jeff Cole. "Their technology has the potential to make a significant global impact in preventing orthopedic implant infections." Dr. Jeff Brown, co-founder of Merge Medical and host of the Merge Medical Startup Podcast, shared, "We had a great time learning more about Silver Bullet. We look forward to releasing their podcast episode before the orthopedic academy meeting in March and introducing them to physicians and medical device executives within our network." "Our partnerships feel like a force multiplier," adds Dr. Cole. "Pitch Sink has captured the attention of some of the largest innovation groups in the U.S., amplifying our reach and allowing us to share incredible stories. Orthopedics hasn't seen many truly transformative advances in recent decades beyond locking screws. When we encountered Silver Bullet Therapeutics' breakthrough technology, we knew this was the kind of company we wanted to support." Both co-founders of Merge Medical have joined the Scientific Advisory Board of Silver Bullet Therapeutics. The Merge Medical podcast featuring Paul Chirico and Silver Bullet Therapeutics is scheduled to air on March 2, 2025, and will be available at mergemedical.org and on YouTube (@mergemedical/podcasts). Silver Bullet Therapeutics was also pleased to announce the in vivo biofilm publication titled, "Biofilm formation on metal alloys and coatings, zirconia, and hydroxyapatite as implant materials in vivo" that was born out of the R&D relationship with Straumann. It stated, "In conclusion, all noble alloys showed benefits concerning plaque accumulation and bacterial viability with AgPt [Silver Bullet Therapeutics AntiBacterIon™] as the most promising alloy followed by AgAuPd and PA." Silver Bullet Therapeutics has built an extensive intellectual property portfolio that has allowed the company to develop and validate coating processes for a wide variety of metallic, polymer, and electronic medical devices. About Silver Bullet Therapeutics Silver Bullet Therapeutics, Inc., located in San Jose, CA, has developed and patented antimicrobial coatings to address surgical-site and hospital-acquired infections by preventing microbial colonization of implanted medical devices. The Company's first product, the OrthoFuzIon Bone Screw System, utilizes Silver Bullet Therapeutics proprietary blend of platinum and silver technology, called AntiBacterIon, that allows for rapid ionization of silver and creation of an antimicrobial zone around a bone screw anywhere in the body. Silver Bullet Therapeutics has already developed and validated processes to allow coating of a wide range of devices including both metallic and polymer devices. OrthoFuzIon™ and AntiBacterIon™ are Trademarks of Silver Bullet Therapeutics, Inc. and is pending FDA clearance and not yet approved for sale in the United States. SOURCE Silver Bullet Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

PARSIPPANY, N.J., Jan. 9, 2025 /PRNewswire/ -- Onkos Surgical, a leading provider of innovative solutions for complex orthopaedic procedures, today announced that its revolutionary NanoCept Antibacterial Technology has been used successfully in multiple surgical procedures. NanoCept is a novel antibacterial coating applied to orthopaedic implants to help address intraoperative bacterial contamination. Continue Reading NanoCept™ Antibacterial Technology "Limb salvage and revision procedures are challenging, and the rate of complication is much higher than most index orthopaedic procedures," said Steven Gitelis, MD, Director of Musculoskeletal Oncology at Rush University Medical Center and Chief Medical Officer of Onkos Surgical. "The risk of implant infection is on my mind every time I take a patient to the operating room, and this is especially true for patients with bone cancer, as they are more susceptible. The NanoCept Technology represents a significant advancement in the preventative measures my colleagues and I use to mitigate the potentially devastating complications related to intraoperative bacterial contamination of implants. It has the potential to create a paradigm shift in implant selection and is a valuable tool surgeons will now have that may help address an unsolved clinical problem." Orthopaedic implant-related infections are clinically challenging and have significant negative effects on patients. Periprosthetic joint infection (PJI) has a lower survival rate than several forms of cancer1 and is expected to cost the U.S. healthcare system up to $1.8 billion dollars by 2030.2 It is estimated that 60-70% of all early and delayed-onset PJI (<3 months and 12-24 months post-surgery) are initiated at the time of the procedure through intraoperative contamination.3 Onkos received De Novo market authorization from the Food and Drug Administration (FDA) in April of 2024 for its NanoCept Antibacterial Technology. Data submitted to support the De Novo application showed that NanoCept has up to a 99.999% (5-log reduction) kill rate in standardized in-vitro testing of bacteria that are commonly found in the operating room environment. The initial FDA authorization for NanoCept was for the Company's ELEOS™ Limb Salvage System, which is a modular total joint system used for patients with bone loss. "The successful completion of these initial surgeries is a key achievement and significant milestone in our strategy to deploy the NanoCept Technology across our portfolio," said Patrick Treacy, Onkos CEO and Co-founder. "We believe NanoCept is a platform technology that will substantially extend our reach and capability in broad orthopaedic markets, and we are actively working to expand regulatory clearances beyond ELEOS to include implants used in orthopaedic reconstruction due to tumor, trauma and other orthopaedic revision procedures." About Onkos Surgical Onkos Surgical is a leader in innovative solutions for complex orthopaedic conditions. With our novel product portfolio, surgeons are better informed about patient-specific clinical challenges and are able to plan and implement more precise reconstructions. Our personalized approach supports improved patient outcomes and experiences using the latest innovations in antibacterial implant coatings, virtual surgical planning, 3D anatomic modeling and printing, implant design, and workflow optimization. More than 350 of the leading academic medical institutions in the US choose Onkos for their complex revision and tumor orthopaedic cases. For more information on Onkos Surgical and its products and services, please visit . Forward Looking Statements Certain statements made in this release that are not statements of historical or current facts are forward-looking statements which involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance, or achievements of the company to be materially different from historical results or from any future results or projections expressed or implied by such forward-looking statements. In many cases, forward-looking statements can be identified by terms such as "future," "believes," "expects," "may," "will," "should," "potential," "estimates," "intends," "anticipates" or "plans" or the negative of these terms or other comparable terminology. Forward-looking statements are based upon management's beliefs, assumptions and current expectations but are subject to known and unknown risks and uncertainties including, without limitation, launch delays and the possibility that post-market clinical results may be inconsistent with the in-vitro preclinical test results. Although management believes that the expectations reflected in the forward-looking statements are reasonable, forward-looking statements are not and should not be relied upon as a guarantee of future performance or results. The forward-looking statements included are made only on the date of this release. The company assumes no obligation to update any information or forward-looking statement contained herein, save for any information required to be disclosed by law. Media Contacts: Sean P. Curry Chief Commercial Officer Onkos Surgical [email protected] 973.264.5400 Alyssa Paldo Vice-President, Media Relations Specialist FINN Partners [email protected] 847.791.8085References1,2 – Premkumar et.al. Projected economic burden of periprosthetic joint infection of the hip and knee in the United States. The Journal of Arthroplasty. Volume 36, Issue 5 P1484-1489.E3May 20213 - Tande AJ, Patel R. Prosthetic joint infection. Clin Microbiol Rev. 2014 Apr;27(2):302-45. doi: 10.1128/CMR.00111-13. PMID: 24696437; PMCID: PMC3993098. SOURCE Onkos Surgical WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Webinar being held today "Evolving strategic context for phages, Introducing new opportunities" to present PHAXIAM Therapeutics strategyBased on the positive evolution in phages therapy market, PHAXIAM’s development strategy could allow the Company to reach operating profitability and positive free cash flow in 2027 Lyon (France) – November 27, 2024, at 02:30 p.m. CET – PHAXIAM Therapeutics (Euronext: PHXM - FR0011471135), a biopharmaceutical company developing innovative treatments for severe and resistant bacterial infections, presented an ambitious development strategy to take advantage of the rapidly evolving phage therapy area. Webinar summary This Wednesday, November 27, 2024, PHAXIAM's management is holding a presentation webinar "Evolving strategic context for phages, Introducing new opportunities" as well as a round table on the theme "Critical need for individualized phage treatments in Europe" with the participation of experts: Dr. Robert SEBBAG (MD, Infectiologist, La Pitié-Salpêtrière – Paris)Dr. Antonia SCOBIE (MD, Infectious Disease Specialist, Royal Free London NHS Foundation Trust – London)Prof. Dr. med. Volker ALT (MD, Director and Chairman of Department of Trauma Surgery University Medical Centre – Regensburg) Dr. Truong-Thanh PHAM (MD, Infectious Disease Specialist, Geneva University Hospitals – Geneva) Following major topics related to Phages Therapy addressed during this webinar: Millions of patients experience unresolved resistant bacterial/ difficult-to-treat infections every year. Facing this critical medical need, there is a strong demand from Physicians for Phages therapy.Concurrently with its classical clinical development pathway (Phages Therapy Medical Product = PTMP), EMA has opened options for the commercialization of Individualized Phages Therapy (IPT) through magistral preparations. PTMP and IPT Models are complementary and synergistic approaches that can be managed by PHAXIAM with limited additional resources. PTMP and IPT form together a self-reinforcing virtuous cycle for Phages therapy: (1) Commercial success in IPT will help finance PTMP programs and facilitate rapid uptake of future approved medicinal products, (2) Success (clinical validation) in PTMP will help broaden clinical and market acceptance of IPT in areas not yet addressable by PTMP. Outlook PHAXIAM will benefit from these two complementary strategic pillars (PTMP and IPT): IPT model, based on the extension of its personalized treatments internationally, to drive and secure short term revenues (2026-2030), with a potential of ~€20m revenues in 2027 and of at least ~€100m revenues in 2030 by treating patients in the most important European countries, in which magistral preparations are common practices,PTMP model, with existing AAC, revenues to be increased owing to additional AAC filings, complemented by a potential conditional market approval (CMA) for the Prosthetic Joint Infections Clinical development, based on the GLORIA study, with potential revenues of ~€8m in 2027 and potentially reaching ~€100m in 2030. With this strategy being implemented PHAXIAM expects to reach operating profitability and positive free cash flow in 2027. Webinar replay The replay of the webinar will be available in English, with French subtitles, on the Company's website in the coming days in the Investors section. About PHAXIAM Therapeutics PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. PHAXIAM is listed on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes For more information, please visit www.phaxiam.com Contacts PHAXIAMThibaut du FayetCEO+33 4 78 74 44 38 investors@phaxiam.comNewCap Mathilde Bohin / Dušan OrešanskýInvestor RelationsArthur RouilléMedia Relations+33 1 44 71 94 94 phaxiam@newcap.eu Forecast information This press release contains forward-looking statements, forecasts and estimates with respect to the clinical programs, development plans, business and regulatory strategy and anticipated future performance of PHAXIAM and of the market in which it operates. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. All statements contained in this press release other than statements of historical facts are forward-looking statements. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond PHAXIAM’s control. Therefore, actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Investor should carefully read the risk factors section of the Company which can be found in the Company’s regulatory filings with the French Autorité des Marchés Financiers (AMF), including in the Company’s 2023 Universal Registration Document (Document d’Enregistrement Universel) filed with the AMF on April 5, 2024 and future filings and reports by the Company. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. PHAXIAM disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in PHAXIAM’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by law. Attachment Phaxiam_PR_Webinar-KOL_EN